Report criticizes French hepatitis B vaccination campaign

PARIS (Reuters Health) Nov 20 - A report on France’s controversial hepatitis B vaccination campaign in the mid-nineties has slammed the government for failing to assess possible side effects properly beforehand. The campaign was launched in 1994 and over the next 3 years, more than 70 million doses were used and an automatic vaccination programme was set up in schools. But it was dropped in 1998 after hundreds of reports of side effects had been logged, and has not yet been re-instated.

The report’s author, Dr. Marc Girard, says his investigation "shows the public powers supported a massive vaccination campaign, costing an estimated 1.5 billion euros, without possessing a reliable enough drug monitoring system to assess the secondary effects of the medication," according to extracts printed in the French newspapers Le Parisien and Le Figaro. Dr. Girard, who had access to numerous documents from the French health product safety agency and the drug-monitoring centre in Strasbourg, accuses the health authority of "distortion" and "dissimulation."

The report was ordered by Judge Marie-Odile Bertella-Geffroy, currently presiding over a negligence case brought by the families of eight people—four of whom have died—who claim they
developed neurological problems as a result of participating in the hepatitis B vaccination campaign.

In all, some 200 complaints have been lodged over the last few years, mainly from people with multiple sclerosis. According to Dr. Girard, "health authorities worked to minimise the situation." He estimates the number of individuals with neurological problems as a result of the vaccine to be in the thousands. Officially, pharmacovigilance centres have reported 900 cases of MS possibly arising from the vaccine.

Following anecdotal reports linking the hepatitis B vaccine with the onset of multiple sclerosis, the World Health Organisation recently undertook a review of all data on the subject and determined there was not enough evidence to support a causal association between the vaccine and MS.

However, a memo from the French General Directorate for Health, dated February 15, 2002, stated that the hepatitis B campaign produced the "greatest series of side effects noted by pharmacovigilance since its creation in 1974." Dr. Girard says the documents he has seen appear to show that crucial evidence on vaccine tolerance was withheld from doctors so as not to ruin the vaccination drive. He goes on to slam the health administration for "collaborating intensively with the vaccine manufacturers."

The pharmaceutical companies Pasteur-Merieux MSD (now Aventis Pasteur-MSD) and SmithKline Beecham (now GlaxoSmithKline) also are criticised for exaggerating the number of hepatitis B carriers and patients in France and of dramatising the dangers of the virus to justify mass vaccination beyond high-risk groups. Dr. Girard also alleges that there have been conflicts of interest. He points out that studies clearing the vaccines of links to neurological problems have been financed by the industry.

Report Criticizes French Hepatitis Vaccination Campaign

PARIS (Reuters Health) Nov 20 - A report on France’s controversial hepatitis B vaccination campaign in the mid-nineties has slammed the government for failing to assess possible side effects properly beforehand. The campaign was launched in 1994 and over the next 3 years, more than 70 million doses were used and an automatic vaccination programme was set up in schools. But it was dropped in 1998 after hundreds of reports of side effects had been logged, and has not yet been re-instated.

The report’s author, Dr. Marc Girard, says his investigation "shows the public powers supported a massive vaccination campaign, costing an estimated 1.5 billion euros, without possessing a reliable enough drug monitoring system to assess the secondary effects of the medication," according to extracts printed in the French newspapers Le Parisien and Le Figaro.

Dr. Girard, who had access to numerous documents from the French health product safety agency and the drug-monitoring centre in Strasbourg, accuses the health authority of "distortion" and "dissimulation."

The report was ordered by Judge Marie-Odile Bertella-Geffroy, currently presiding over a negligence case brought by the families of eight people—four of whom have died—who claim they developed neurological problems as a result of participating in the hepatitis B vaccination campaign. In all, some 200 complaints have been lodged over the last few years, mainly from people with multiple sclerosis.

According to Dr. Girard, "health authorities worked to minimise the situation." He estimates the number of individuals with neurological problems as a result of the vaccine to be in the thousands. Officially, pharmacovigilance centres have reported 900 cases of MS possibly arising from the vaccine.

Following anecdotal reports linking the hepatitis B vaccine with the onset of multiple sclerosis, the World Health Organisation recently undertook a review of all data on the subject and determined there was not enough evidence to support a causal association between the vaccine and MS. However, a memo from the French General Directorate for Health, dated February 15, 2002, stated that the hepatitis B campaign produced the "greatest series of side effects noted by pharmacovigilance since its creation in 1974."

Dr. Girard says the documents he has seen appear to show that crucial evidence on vaccine tolerance was withheld from doctors so as not to ruin the vaccination drive. He goes on to slam the health administration for "collaborating intensively with the vaccine manufacturers."

The pharmaceutical companies Pasteur-Merieux MSD (now Aventis Pasteur-MSD) and SmithKline Beecham (now GlaxoSmithKline) also are criticised for exaggerating the number of hepatitis B carriers and patients in France and of dramatising the dangers of the virus to justify mass vaccination beyond high-risk groups. Dr. Girard also alleges that there have been conflicts of interest. He points out that studies clearing the vaccines of links to neurological problems have been financed by the industry.